美国医疗器械追溯要求分析与思考.pdfVIP

中国药物警戒第9 卷第10 期 2012 年10 月 October, 2012, Vol.9, No.10 中图分类号：R197.39 文献标识码：A 文章编号：1672-8629（2012 ）10-0601-04 美国医疗器械追溯要求分析与思考 1 2 1 2 贾健雄 孟刚 （国家食品药品监督管理局医疗器械技术审评中心，北京 100044 ；中国医学装备协会计量测量专 业委员会，北京 100044 ） 通过对美国医疗器械上市后追溯相关 规、 及产品、生产商和经销商各自的责任进行分析，归纳其追溯制 摘要： 度、检查措施和产品清单特点，提出上市前的实验 研究数据、动物试验数据及小样本短期临床数据并不能完全表 征该器械的全部性能，医疗器械的远期安全性及有效性必须经过严谨的长期临床随访才能获得。建议在我国为特 定高风险医疗器械制定具体的追溯要求，在保证该类产品可追溯性的同时对产品的远期临床效果进行科学评价， 以高风险产品和新注册产品追溯制度的制定颁布为 规基础，以重新注册为技术手段，以生产企业、国内代理企业 为实施主体，构建追溯体系；同时发挥行业协会咨询、协调、监督、服务企业的社会职能，加强企业自律，为上市后产 品可追溯性建立 性运转机制，保障公众用械安全、有效。 医疗器械；追溯；心脏瓣膜 关键词： Analysis and Ponder of American Medical Device Trace Requirements 1 2 1 2 JIA Jian-xiong MENG Gang ( Center For Medical Device Evaluation, SFDA, Beij ing 100044, China; China Association Of Medical Equipment, CAME, Beijing 100044, China) Abstract:This paper mainly analyzes the requirements of American medical equipment listed trace, and concludes its characteristics, such as laws and regulations, involving products, manufacturers and distributors responsibility, and summarizes its traceability system, inspection measures and product list characteristics, and then puts forward that the premarket laboratory research data, animal test data and small sample short -term clinical data can not fully express the instrument of all performance medical devices forward safety and effectiveness, and must go through long -term clinical follow -up to obtain the information. The proposal is to establish a particular high -risk implanted medical device listed trace in our country, in order to ensure the traceability of products and good for scientific evaluation with the long -term clinical results. To construct traceability system based on the high-risk products and new registere